Body fluid component separating device

Abstract

A body fluid component separating device may comprise: a housing having a sealed space; a piston which is accommodated in the housing so as to be sealed by the housing, is configured to be movable in the longitudinal direction of the housing, and includes a first partition, a second partition, and a fluid passage connected to the first partition and the second partition; a needle which is at least partially accommodated in the sealed space, and includes a needle upper portion fixed to the housing and a needle lower portion configured to be movable with respect to the needle upper portion by movement of the piston; and a needle support connecting the needle lower portion to the piston such that the needle lower portion maintains a fixed position with respect to the piston.

Description

Body fluid component separation device

[0001] The disclosure relates to a device for separating body fluid components.

[0002] Human body fluids, such as blood and bone marrow, contain various active ingredients and cells. Among these, plasma contained in blood is a neutral yellow liquid component obtained by separating and removing red blood cells from the blood. Platelet-rich plasma (PRP), obtained by centrifuging plasma, performs various functions in vivo, including acting as glue, blood coagulation and hemostasis, acting as a scaffold for the migration and differentiation of stem cells and primary cells, regulating angiogenesis, anti-inflammatory action, antibacterial action, and analgesic action. In particular, as it is associated with tissue regeneration, such as cell proliferation, differentiation promotion, and angiogenesis in tendons, ligaments, cartilage, and muscles, the clinical efficacy of PRP in cases of musculoskeletal injury is receiving attention. For example, Korean Patent Publication No. 10-2019-0059019 discloses a blood component centrifugation device.

[0003] The aforementioned background technology was possessed or acquired during the process of deriving the present disclosure and cannot be considered as prior art disclosed to the general public prior to the filing of the present disclosure.

[0004] One aspect of the present disclosure may provide a body fluid component separation device capable of efficiently separating a target substance from body fluids.

[0005] A body fluid component separation device according to one embodiment may include a housing having a sealed space, a piston configured to be received in the housing so as to be sealed with the housing and movable along the longitudinal direction of the housing, wherein the piston comprises a first partition for defining a first space in the sealed space, a second partition for defining a second space located below the first space in the sealed space, and a fluid passage for defining a third space connected to the first partition and the second partition and fluidly communicating the first space and the second space, a needle at least partially received in the sealed space, wherein the needle comprises a needle upper portion fixed to the housing and a needle lower portion configured to be movable relative to the needle upper portion by the movement of the piston, and a needle support connecting the needle lower portion and the piston so that the needle lower portion maintains a fixed position relative to the piston.

[0006] The lower end of the needle may be located in the third space.

[0007] The above needle support may include a support body and a plurality of support arms extending from the support body to the piston.

[0008] The above multiple support arms may have a preload.

[0009] The above plurality of support arms can be inclined with respect to the support body.

[0010] The above needle support may include an elastic material.

[0011] The upper part of the needle and the lower part of the needle may overlap at least partially.

[0012] The diameter of the upper part of the needle may be larger than the diameter of the lower part of the needle.

[0013] The first partition and the second partition may be inclined in opposite directions.

[0014] The body fluid component separation device may further include a manipulator operably coupled to the piston, configured to control the movement of the piston between a first position and a second position located below the first position.

[0015] The above manipulator may include a handle, a first engagement member formed on the handle, a second engagement member configured to engage with the first engagement member, a shaft coupled to the second engagement member, a first engagement element formed on the shaft, and a second engagement element configured to engage with the first engagement element and installed on the piston.

[0016] The first engagement element may be a male engagement element, and the second engagement element may be a female engagement element.

[0017] The housing may include a container that maintains a seal with the piston, and a lid that seals the container and is coupled to the container to define the sealed space, wherein the lid may include an opening that fluidly communicates with the sealed space and into which the upper portion of the needle is at least partially inserted, and a plug that is deformable and opens and closes the opening.

[0018] The piston may include an outer body that moves along the longitudinal direction of the housing, and an inner body located inside the outer body. The inner body may be configured so that rotational force of the shaft is not transmitted to materials located in the first space, the second space, and the third space when the shaft rotates. The inner body may prevent materials located in the first space, the second space, and the third space from contacting the shaft, the first engagement element, and the second engagement element.

[0019] The piston may be configured to receive a target material including a first material, a second material, and a third material, and the handle and the second engaging member may be configured to operate to position the first material in the first space, position the second material in the second space, and position the third material in the third space.

[0020] The body fluid component separation device may further include a piston guide configured to prevent rotation of the piston and guide its movement.

[0021] A body fluid component separation device according to one embodiment may include a housing comprising a container and a lid defining a space sealed to the outside; a piston configured to separate the sealed space of the housing into a first space and a second space, fluidly connect the first space and the second space, and move along the longitudinal direction of the container along the inner surface of the container; a first needle at least partially received in the sealed space of the housing, wherein the first needle comprises a needle upper portion fixed to the lid and a needle lower portion configured to move relative to the needle upper portion by the movement of the piston; and a needle support connecting the needle lower portion and the piston so that the needle lower portion maintains a fixed position relative to the piston. The needle support may include a support body that at least partially surrounds the needle lower portion and a support arm connecting the support body and the piston.

[0022] The piston comprises an outer body that moves along the longitudinal direction of the container and an inner body located inside the outer body, and the needle support may be connected to the inner body.

[0023] The support body may include a needle hole into which the lower part of the needle is inserted.

[0024] The diameter of the lower part of the needle may be larger than the diameter of the upper part of the needle.

[0025] The diameter of the lower part of the needle may be smaller than the diameter of the upper part of the needle.

[0026] The piston comprises a first partition defining the first space, a second partition located below the first space and defining the second space, and a fluid passage connecting the first partition and the second partition and fluidly communicating the first space and the second space, defining the third space, and the lower end of the needle may be located in the third space.

[0027] The above-mentioned lid includes a first opening, a second opening, and a third opening capable of fluid communication with the above-mentioned sealed space, wherein the first opening is located at the center of the lid, and the second opening and the third opening may be located at the periphery of the lid surrounding the center.

[0028] The above lead includes a first plug for opening and closing the first opening, a second plug for opening and closing the second opening, and a third plug for opening and closing the third opening, and the first plug, the second plug, and the third plug may be configured to be deformable.

[0029] The first needle is inserted at least partially into the first opening, and the body fluid component separation device may further include a second needle inserted at least partially into the second opening or the third opening.

[0030] The above-described body fluid component separation device further includes a manipulator configured to move the piston relative to the housing, and the manipulator may include a shaft having a rotation axis and configured to be rotatable about the rotation axis, a male engagement element formed along the axial direction of the rotation axis of the shaft, and a female engagement element configured to engage with the male engagement element.

[0031] The piston may include an outer body that moves along the longitudinal direction of the container, and an inner body located inside the outer body. The shaft, the male engagement element, and the female engagement element may be located at least partially inside the inner body. The inner body may be configured so that materials located in a sealed space of the housing do not come into contact with the shaft, the male engagement element, and the female engagement element.

[0032] The inner body comprises a first longitudinal portion having a first inner diameter and a second longitudinal portion connected to the first longitudinal portion and having a second inner diameter smaller than the first inner diameter, a step is formed between the first longitudinal portion and the second longitudinal portion, and the arm engagement element may be limited by the step.

[0033] The above-described body fluid component separation device may further include a piston guide connected to the lead and configured to guide the movement of the piston. The inner body is located inside the piston guide, and at least a portion of the outer surface of the inner body may contact at least a portion of the inner surface of the piston guide. The inner body and the piston guide may be positioned at an angle with respect to the central axis of the container. The inner body and the piston guide may be configured to prevent rotation of the piston. The inner body may be configured so that the rotational force of the shaft is not transmitted to materials located in the sealed space of the housing when the shaft rotates.

[0034] A body fluid component separation device according to one embodiment may include a housing comprising a container and a lid defining a space sealed to the outside, a piston configured to be movable along the longitudinal direction of the container along the inner surface of the container, and a needle at least partially received in the sealed space of the housing. The piston may include a partition separating the sealed space of the housing into a first space and a second space, and an indicator configured to indicate a layer comprising a target substance flowing from the first space to the second space, the third space being connected to the partition and fluidly communicating with the first space and the second space. The needle may be at least partially positioned in the third space and may include a needle fixing portion fixed to the lid, and a needle moving portion fixed to the indicator, at least partially overlapping with the needle fixing portion, and configured to move along the outer surface of the needle fixing portion when the piston moves. The piston may be configured to move in a direction away from the lid to position the target substance in the third space. The needle moving part may be configured such that when the target material is located in the third space, the lower end of the needle fixing part and the lower end of the needle moving part are located on the same plane or the lower end of the needle moving part is located below the lower end of the needle fixing part, and the lower end of the needle moving part is located at a certain position in the third space.

[0035] The length of the above needle moving part may be less than or equal to the length of the above needle fixing part.

[0036] The inner diameter of the above-mentioned needle moving part may be the same as the outer diameter of the above-mentioned needle fixing part.

[0037] The indicator may further include a needle support located in the third space that connects the needle moving part and the indicator so that the needle moving part is fixed to the indicator. The indicator may include an inner surface of the indicator defining the third space, and an outer surface of the indicator opposite to the inner surface of the indicator. The needle support may include a support body that at least partially surrounds the needle moving part, and a plurality of support arms. Each support arm extends from the support body to the inner surface of the indicator, and the plurality of support arms may be arranged circumferentially along the inner surface of the indicator.

[0038] The indicator may include a first indicator end connected to the partition and a second indicator end opposite to the first indicator end, and the needle support may be positioned immediately adjacent to the second indicator end.

[0039] A body fluid component separation device according to one embodiment can efficiently separate a target substance from body fluid. The effects of the body fluid component separation device according to one embodiment are not limited to those mentioned above, and other unmentioned effects will be clearly understood by a person skilled in the art from the description below.

[0040] The above-described and other aspects, features, and advantages of specific embodiments of the present disclosure will become apparent from the following detailed description with reference to the accompanying drawings.

[0041] FIG. 1 is a perspective view of a body fluid component separation device according to one embodiment.

[0042] FIG. 2 is an exploded perspective view of a body fluid component separation device according to one embodiment.

[0043] Figure 3 is a cross-sectional view of the body fluid component separation device of Figure 1 as viewed from AA.

[0044] FIG. 4 is a cross-sectional view of the body fluid component separation device of FIG. 1 viewed from AA, showing the state in which the piston of FIG. 3 is moved downward.

[0045] FIG. 5 is a perspective view of a body fluid component separation device according to one embodiment.

[0046] FIG. 6 is an exploded perspective view of a body fluid component separation device according to one embodiment.

[0047] Figure 7 is a cross-sectional view of the body fluid component separation device of Figure 5 as viewed from AA.

[0048] Figure 8 is a cross-sectional view of the body fluid component separation device of Figure 7 as viewed from BB.

[0049] FIG. 9 is a plan view of the lead of a body fluid component separation device according to one embodiment.

[0050] FIG. 10 is an operation diagram of a body fluid component separation device according to one embodiment.

[0051] FIG. 11 is a perspective view of a body fluid component separation device according to one embodiment.

[0052] FIG. 12 is an exploded perspective view of a body fluid component separation device according to one embodiment.

[0053] Figure 13 is a cross-sectional view of the body fluid component separation device of Figure 1 as viewed from AA.

[0054] Fig. 14 shows the piston of the body fluid component separation device of Fig. 3.

[0055] FIG. 15 is a plan view of a piston according to one embodiment.

[0056] FIG. 16 is a plan view of the lead of a body fluid component separation device according to one embodiment.

[0057] FIGS. 17 and 18 are operation diagrams of a body fluid component separation device according to one embodiment.

[0058] Hereinafter, embodiments are described in detail with reference to the attached drawings. However, various modifications may be made to the embodiments, and thus the scope of the patent application is not limited or restricted by these embodiments. It should be understood that all modifications, equivalents, and substitutions to the embodiments are included within the scope of the rights.

[0059] The terms used in the embodiments are for illustrative purposes only and should not be interpreted as intended to be limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as "comprising" or "having" are intended to indicate the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not precluding the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0060] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as generally understood by those skilled in the art to which the embodiments pertain. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an ideal or overly formal sense unless explicitly defined in this application.

[0061] In addition, when describing with reference to the attached drawings, identical components are assigned the same reference numeral regardless of drawing symbols, and redundant descriptions thereof are omitted. When describing embodiments, if it is determined that a detailed description of related prior art could unnecessarily obscure the essence of the embodiment, such detailed description is omitted.

[0062] In addition, terms such as first, second, A, B, (a), (b), etc., may be used when describing the components of the embodiments. These terms are intended only to distinguish the components from other components, and the nature, order, or sequence of the components is not limited by the terms. Where it is stated that a component is "connected," "combined," or "connected" to another component, it should be understood that the component may be directly connected or connected to the other component, but that another component may also be "connected," "combined," or "connected" between each component.

[0063] Components included in any one embodiment and components having common functions shall be described using the same names in other embodiments. Unless otherwise stated, the description in any one embodiment may also apply to other embodiments, and specific descriptions shall be omitted to the extent of overlap.

[0064] Referring to FIGS. 1 to 4, the body fluid component separation device (10) can separate a target substance from a body fluid to be separated. For example, platelet-rich plasma (PRP) can be separated from blood. The body fluid component separation device (10) can receive body fluid and separate the received body fluid into multiple layers using centrifugation. For example, when blood is centrifuged, the body fluid component separation device (10) can be configured to extract PRP from the buffy coat layer among the multiple layers. The body fluid component separation device (10) may include a housing (110), a piston (120), a manipulator (130), a needle (140), and a needle support (150).

[0065] The housing (110) may accommodate a piston (120), at least a portion of a manipulator (130), at least a portion of a needle (140), and a needle support (150). The housing (110) may include a container (111) and a lid (112). The container (111) and the lid (112) may define a space enclosed from the outside in the housing (110).

[0066] The container (111) may have a cylindrical shape having a central axis (C-C'). Additionally, the container (111) may have an open upper end, a closed side, and a closed lower end. The container (111) may have a recessed step (111A) in the radial direction of the container (111) at the open upper end.

[0067] The container (111) may be formed of a substantially transparent material or a substantially translucent material so that the interior of the container (111) can be seen from the outside of the container (111). The user can check the amount of body fluid to be separated present inside the container (111), and the movement of substances in the body fluid separated into multiple layers.

[0068] The lid (112) can seal the open upper end of the container (111). The lid (112) may include a plate (113), a plug (114), a sealing cap (115A), a sealing ring (115B), and a piston guide (116).

[0069] The plate (113) can cover the open upper end of the container (111). Corresponding to the cylindrical container (111), the plate (113) may substantially have a disc shape. The plate (113) can be attached to the step (111A) of the container (111) at the open upper end of the container (111).

[0070] The plate (113) may include a first opening (O1) and a second opening (O2). The first opening (O1) and the second opening (O2) may be formed to penetrate the plate in the axial direction of the central axis (C-C') and may have a substantially circular shape. The first opening (O1) may be located at the center of the plate (113), and the second opening (O2) may be located at the periphery of the plate (113).

[0071] The plate (113) may include a first annular protrusion (P1) and a second annular protrusion (P2). The first annular protrusion (P1) and the second annular protrusion (P2) may protrude from the plate (113) in a direction away from the container (111). The first annular protrusion (P1) may be positioned in a first opening (O1), and the second annular protrusion (P2) may be positioned in a second opening (O2). Additionally, the plate (113) may include a needle coupling portion (C) protruding from the plate (113) toward the inside of the container (111). The needle coupling portion (C) may be positioned in the first opening (O1) opposite to the first annular protrusion (P1) relative to the plate (113).

[0072] The plug (114) can open and close the first opening (O1). The plug (114) may include a coupling member (114A) that can be coupled with an external unit such as a syringe, and a sealing member (114B) that can substantially open and close the first opening (O1). The plug (114) can be coupled to the first annular protrusion (P1).

[0073] The sealing member (114B) may be formed of a soft material such as silicone. Thus, when the coupling member (114A) of the plug (114) is coupled with an external unit, the sealing member (114B) may be deformed so that the first opening (O1) can be opened. Additionally, when the coupling member (114A) of the plug (114) is separated from the external unit, the deformed sealing member (114B) returns to its state before deformation, and the first opening (O1) can be closed again.

[0074] The sealing cap (115A) and sealing ring (115B) can seal between the plate (113) and the control part (137) of the manipulator (130) described later. The second annular protrusion (P2) can surround a part of the shaft (1371) of the control part (137), and the sealing cap (115A) and sealing ring (15B) can be placed between the second annular protrusion (P2) and the shaft (1371).

[0075] The piston guide (116) may be configured to prevent rotation of the piston (120). Additionally, the piston guide (116) may guide the movement of the piston (120). The piston guide (116) may have a cylindrical shape. The piston guide (116) may surround the second opening (O2) and extend toward the inside of the container (111).

[0076] The piston (120) is received inside the container (111) and can move along the inner side of the container (111) in the axial direction of the central axis (C-C'). The piston (120) may include an outer body (121), an inner body (122), a first partition (123A), a second partition (123B), a fluid passage (124), and a piston sealing ring (125). The outer body (121) can move along the longitudinal direction of the housing (110). The inner body (122) may be located inside the outer body (121).

[0077] The outer body (121) and the inner body (122) may each have a substantially cylindrical shape having an open upper end and a lower end. The inner body (122) may be placed in the first partition (123A). Specifically, the lower end of the inner body (122) may be connected to the first partition (123A). At least a portion of the outer surface of the inner body (122) may substantially contact the piston guide (116). When the piston (120) moves in the axial direction of the central axis (C-C'), the inner body (122) of the piston (120) may move along the piston guide (116) and rotation is prevented.

[0078] The inner body (122) may include a first longitudinal portion (1221) having a first inner diameter and a second longitudinal portion (1222) connected to the first longitudinal portion (1221) and having a second inner diameter. The outer diameters of the first longitudinal portion (1221) and the second longitudinal portion (1222) may be the same, and the first inner diameter may be smaller than the second inner diameter. Thus, a step may be formed between the first longitudinal portion (1221) and the second longitudinal portion (1222).

[0079] The first partition (123A) may be connected to the lower end of the outer body (121) and the inner body (122), and may be connected to the upper end of the fluid passage (124). Since the diameter of the fluid passage (124) is smaller than the diameter of the outer body (121), the first partition (123A) may have a truncated cone shape with a diameter decreasing in the direction away from the outer body (121) along the axial direction of the central axis (C-C'), and thus may have inclined sides. Additionally, the lower end of the inner body (122) connected to the first partition (123A) may be inclined. The first partition (123A) may include a shaft hole (H1) connected to the open lower end of the inner body (122).

[0080] The outer body (121), the inner body (122), and the first partition (123A) may define a first space (S1) in a sealed space of the housing (110). For example, the first space (S1) may be defined as a space enclosed by the inner side of the outer body (121), the outer side of the inner body (122), and the inner side of the first partition (123A).

[0081] The second partition (123B) may be connected to the lower end of the fluid passage (124). The second partition (123B) may have a truncated cone shape with a diameter increasing in the direction away from the outer body (121) along the axial direction of the central axis (C-C'). The second partition (123B) may include an inclined portion (123B-2) connected to the lower end of the fluid passage (124) and a flat portion (123B-1) connected to the inclined portion (123B-2) and substantially flat.

[0082] The container (111) and the second partition (123B) may define a second space (S2) in the enclosed space of the housing (110). For example, the second space (S2) may be defined as a space enclosed by the inner side of the container (111) and the inner side of the second partition (123B).

[0083] The fluid passage (124) may have a cylindrical shape connecting the first partition (123A) and the second partition (123B). The space enclosed by the inner side of the fluid passage (124) may be defined as a third space (S3). The fluid passage (124) may include an open upper end and a lower end, so that the third space (S3) may fluidly communicate with the first space (S1) and the second space (S2) and may have a target material located therein.

[0084] The piston sealing ring (125) can be placed in a recess formed on the side of the flat portion (123B-1). The piston sealing ring (125) can maintain a seal between the piston (120) and the container (111).

[0085] The manipulator (130) can move the piston (120) relative to the housing (110). The manipulator (130) can be operably coupled to the piston (120). Here, "operably coupled" means that the manipulator (130) directly drives the piston (120). The manipulator (130) may include a handle (131), a pair of engaging members (136A, 136B), and a control unit (137).

[0086] The handle (131) may be configured to be operated by a user. Here, in addition to being operated by a person, the handle (131) may be operated by a mechanical and / or electrical mechanism. The handle (131) may include a base (132) and a side (133A) connected to the base (132), and may have a substantially cylindrical shape. The handle (131) may include an inner space (134) defined by the base (132) and the side (133A). A plurality of recesses (133B) may be arranged on the side (133A) of the handle (131), extending in the axial direction of the central axis (C-C') and formed along the circumferential direction of the handle (131). By means of the plurality of recesses (133B), the gripping force is increased when the user grasps the handle (131) to operate the handle (131), allowing the handle (131) to be operated with less force. Additionally, the handle (131) may include a hollow protrusion (135) that protrudes from the base (132) toward the inner space (134), and the hollow protrusion (135) may receive a plug (114).

[0087] The handle (131) can be rotatably coupled to the housing (110). Additionally, the handle (131) can be removablely coupled to the housing (110).

[0088] A pair of interlocking members (136A, 136B) may include a first interlocking member (136A) formed on the side of the hollow protrusion (135) and a second interlocking member (136B) operably connected to the adjustment member (137). The first interlocking member (136A) and the second interlocking member (136B) may be operably interlocked with each other. When a user rotates the handle (131), the first interlocking member (136A) formed around the hollow protrusion (135) of the handle (131) also rotates together, and thereby the second interlocking member (136B) engaged with the first interlocking member (136A) rotates, and the adjustment member (137) can be operated.

[0089] The adjustment unit (137) can finely adjust the movement of the piston (120). Additionally, the adjustment unit (137) can fix the piston (120) in place. The adjustment unit (137) may include a shaft (1371), a male engagement element (1372), and a female engagement element (1373).

[0090] The shaft (1371) has a rotation axis (R-R') and can rotate about the rotation axis (R-R'). The adjustment part (137) can rotate about the rotation axis (R-R') by the rotation of the shaft (1371). The shaft (1371) may include a coupling part (1375) in which a head (1374) installed on the plate (113) and a second engaging member (136B) are disposed. The head (1374) is disposed on the upper surface of the plate (113), and a sealing cap (115A) and a sealing ring (115B) may be disposed between the head (1374) and the second annular protrusion (P2). The coupling part (1375) may define the upper end of the shaft (1371) as a part located above the head (1374) and above the sealing cap (115A).

[0091] The male engagement element (1372) is formed along the axial direction of the rotation axis (R-R') of the shaft (1371) and may have a predetermined pitch. The male engagement element (1372) may be formed spirally on the portion of the shaft (1371) located below the plate (113). The shaft (1371) and the male engagement element (1372) can be understood as forming a rigid screw structure. The female engagement element (1373) engages with the male engagement element (1372) and may have a pitch corresponding to the pitch of the male engagement element (1372). The female engagement element (1373) can be understood as forming a nut structure. The pitch of the male engagement element (1372) and the pitch of the female engagement element (1373) may be determined based on the user's handle (131) rotation angle and the travel distance of the piston (120). In addition, if the pitch is too large, the shaft (1371) may rotate and the piston (120) may move due to the force applied to the piston by an external force (e.g., centrifugal force), so the pitch can be determined within an appropriate range so that the shaft (1371) does not rotate due to the external force while minimizing the operation of the handle (131).

[0092] The arm engagement element (1373) can be formed on the inner surface of the first longitudinal portion (1221) of the piston (120). Accordingly, the arm engagement element (1373) can move together with the piston (120).

[0093] The mutual interlocking of the male interlocking element (1372) and the female interlocking element (1373) as described above ensures the movement of the piston (120) and enables the user to fix the piston (120) at a desired position.

[0094] The inner body (122) is configured so that when the shaft (1371) rotates and the control unit (137) rotates, the rotational force of the control unit (137) is not transmitted to the materials located in the first space (S1), the second space (S2), and the third space (S3), and isolates the materials located in the first space (S1), the second space (S2), and the third space (S3) and the control unit (137) so that they do not come into contact with each other.

[0095] The needle (140) may be configured to inject the fluid to be separated into the container (111). In addition, the needle (140) may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10) to the outside of the container (111). The needle (140) may be at least partially accommodated in a sealed space of the housing (110). The needle (140) may include a needle upper portion (141) and a needle lower portion (142).

[0096] The needle upper portion (141) can be inserted into the first opening (O1). By doing so, the needle upper portion (141) can be accommodated at least partially in the sealed space of the housing (110). The needle upper portion (141) can be fixed in position relative to the housing (110), specifically relative to the lead (112), by being coupled to the needle coupling portion (C). The needle upper portion (141) may have a cylindrical shape having an open upper end and a lower end.

[0097] The lower needle (142) may overlap at least partially with the upper needle (141) by being partially inserted into the open lower end of the upper needle (141). The lower needle (142) may be connected to the piston (120) by a needle support (150) to be described later, and thus configured to be movable relative to the upper needle (141) by the movement of the piston (120). The lower needle (142) may have a cylindrical shape having an open upper end and an open lower end. The outer diameter of the upper needle (141) may be larger than the outer diameter of the lower needle (142). The inner diameter of the upper needle (141) is substantially the same as the outer diameter of the lower needle (142), so that the lower needle (142) can move smoothly relative to the upper needle (141), and so that fluid passing through the needle (140) does not leak through the space between the upper needle (141) and the lower needle (142).

[0098] The needle support (150) can connect the needle (140) and the piston (120). Specifically, it can connect the lower part of the needle (142) and the piston (120). The needle support (150) may include a support body (151) and a plurality of support arms (152).

[0099] Each of the plurality of support arms (152) may extend from the support body (151) to the piston (120). For example, it may extend from the support body (151) to the inner side of the outer body (121) of the piston (120). The plurality of support arms (152) may be seamlessly integrated with the support body (151) and may be arranged along the circumference of the support body (151). The plurality of support arms (152) may be formed to be inclined with respect to the support body (151).

[0100] The support body (151) may include a needle hole (H2) into which the lower part of the needle (142) of the needle (140) is inserted. The needle support (150) may include a third annular protrusion (153A) and a fourth annular protrusion (153B). The third annular protrusion (153A) may be positioned in the needle hole (H2) so as to face the plate (113), and the fourth annular protrusion (153B) may be positioned in the needle hole (H2) opposite to the third annular protrusion (153A) with respect to the support body (151). The third annular protrusion (153A) and the fourth annular protrusion (153B) may surround the lower part of the needle (142) inserted into the needle hole (H2). The lower part of the needle (142) can be fixed to the third annular protrusion (153A) and the fourth annular protrusion (153B).

[0101] The needle support (150) may include an elastic material, and a plurality of support arms (152) may have a preload when installed. Thus, the needle support (150) can substantially fix the position of the needle lower (142) relative to the piston (120). The needle lower (142) may have a fixed position such that, for example, the lower end of the needle lower (142) is located in the third space (S3). Preferably, the fixed position of the needle lower (142) may be a position such that the lower end of the needle lower (142) is located at the center of the third space (S3).

[0102] The body fluid component separation device (10) can be used to separate PRP from blood, in which case PRP becomes the target substance. After one centrifugation using the body fluid component separation device (10), the blood can be separated into plasma, PRP, and red blood cells. Before performing centrifugation using the body fluid component separation device (10), the user can set the position of the piston (120) by operating the handle (131) so that the PRP (target substance) after centrifugation is located in the third space (S3) according to the amount of blood to be centrifuged. After centrifugation is performed, the user can further fine-tune the position of the piston (120) by removing the handle (131) and operating the second engaging member (136B) so that the PRP (target substance) is located at the lower end of the needle lower part (142). Additionally, by means of a needle support (150) that fixes the lower part of the needle (142) and connects it to the piston (120), the position of the lower end of the lower part of the needle (142) can be fixed in the third space (S3) even if the position of the piston (120) moves. As previously mentioned, since the container (111) is formed of a substantially transparent material or a substantially translucent material, the user can visually check the fluid substances separated inside the container after centrifugation, and can move the piston (120) so that each substance is received in the first space (S1), the second space (S2), and the third space (S3) before and after centrifugation by only operating the handle (131) and the second interlocking member (136B). Afterwards, an external unit such as a syringe can be attached to the plug (114) and the PRP contained in the third space (S3) can be extracted outside the body fluid component separation device (10) through the needle (140). Afterwards, additionally, the material contained in the first space (S1) can be extracted outside the body fluid component separation device (10).

[0103] In the case of centrifuging a body fluid such as blood, where the layer containing the target substance is located in the center after centrifugation, the target substance can be extracted from the body fluid component separation device (10) through a needle lower portion (142) having a lower end that is always fixed in the third space (S3) located in the center. Thus, the target substance can be extracted with only one centrifugation.

[0104] Although the embodiments of the present invention described above are described in relation to an embodiment for centrifuging a body fluid in which the layer containing the target substance is located in the center after centrifugation, and the amount of the target substance is relatively small compared to the amount of other substances, it should be understood that the present invention may also be applied to a body fluid in which the target substance is located in a layer other than the center layer and the amount of the target substance is relatively large compared to the amount of other substances. For example, in an embodiment not illustrated, the lower end of the needle lower (142) may be located in the second space (S2), and the needle support (150) may be connected to the inner surface of the container (111) rather than to the inner surface of the piston (120).

[0105] Referring to FIGS. 5 to 10, the body fluid component separation device (10') can separate a target substance from a body fluid to be separated. For example, platelet-rich plasma (PRP) can be separated from blood. The body fluid component separation device (10') can receive body fluid and separate the received body fluid into multiple layers using centrifugation. For example, when blood is centrifuged, the body fluid component separation device (10') can be configured to extract PRP from the buffy coat layer among the multiple layers.

[0106] The body fluid component separation device (10') may include a housing (110'), a piston (120'), a manipulator (130'), a first needle (140A'), a second needle (140B'), and a needle support (150').

[0107] The housing (110') can accommodate a piston (120'), at least a portion of a manipulator (130'), at least a portion of a first needle (140A'), at least a portion of a second needle (140B'), and a needle support (150'). The housing (110') may include a container (111') and a lid (112'). The container (111') and the lid (112') may define a space enclosed with respect to the outside of the housing (110').

[0108] The container (111') may have a cylindrical shape having a central axis (C-C'). Additionally, the container (111') may have an open upper end, a closed side, and a closed lower end. The container (111') may have a step (111A') that is recessed radially from the open upper end of the container (111').

[0109] The container (111') may be formed of a substantially transparent material or a substantially translucent material so that the interior of the container (111') can be seen from the outside of the container (111'). The user can check the amount of body fluid to be separated present inside the container (111'), and the movement of substances in the body fluid separated into multiple layers.

[0110] The lid (112') can seal the open upper end of the container (111'). The lid (112') may include a plate (113'), a first plug (114A'), a second plug (114B'), a third plug (114C'), a sealing cap (115A'), a sealing ring (115B'), a piston guide (116'), and a check valve (117').

[0111] The plate (113') can cover the open upper end of the container (111'). Corresponding to the cylindrical container (111'), the plate (113') may substantially have a disc shape. The plate (113') may be joined to the step (111A') of the container (111') at the open upper end of the container (111'). The plate (113') may include a first plate surface (1131') facing the enclosed space of the housing, and a second plate surface (1132') opposite to the first plate surface (1131').

[0112] The plate (113') may include a first opening (O1'), a second opening (O2'), a third opening (O3'), a fourth opening (O4'), and a fifth opening (O5'). The first opening (O1'), the second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may penetrate the plate (113') from the first plate surface (1131') to the second plate surface (1132'). For example, the first opening (O1'), the second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may penetrate the plate (113') in the thickness direction of the plate (113'). The first opening (O1'), the second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may have a substantially circular shape. The first opening (O1') may be located at the center of the plate (113'). The center of the plate (113') may be defined as the part of the plate (113') including the central axis (C-C'). The second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may be located at the periphery of the plate (113'). The periphery of the plate (113') may be defined as the part of the plate (113') surrounding the center of the plate (113'). The second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may be arranged along the periphery of the plate (113'). In one embodiment, the sizes (e.g., diameters) of the first opening (O1'), the second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may be different from each other. In one embodiment, the sizes (e.g., diameters) of one or more of the first opening (O1'), the second opening (O2'), the third opening (O3'), the fourth opening (O4'), and the fifth opening (O5') may be the same from each other.

[0113] The plate (113') may include a first annular protrusion (P1'), a second annular protrusion (P2'), a third annular protrusion (P3'), a fourth annular protrusion (P4'), and a fifth annular protrusion (P5'). The first annular protrusion (P1'), the second annular protrusion (P2'), the third annular protrusion (P3'), the fourth annular protrusion (P4'), and the fifth annular protrusion (P5') may protrude from the plate (113') in a direction away from the container (111'). The first annular protrusion (P1'), the second annular protrusion (P2'), the third annular protrusion (P3'), the fourth annular protrusion (P4'), and the fifth annular protrusion (P5') may be disposed on the second plate surface (1132'). A first annular protrusion (P1') can be placed in a first opening (O1'), a second annular protrusion (P2') can be placed in a second opening (O2'), a third annular protrusion (P3') can be placed in a third opening (O3'), a fourth annular protrusion (P4') can be placed in a fourth opening (O4'), and a fifth annular protrusion (P5') can be placed in a fifth opening (O5').

[0114] The plate (113') may include a first needle coupling portion (C1'), a second needle coupling portion (C2'), and a third needle coupling portion (C3'). The first needle coupling portion (C1'), the second needle coupling portion (C2'), and the third needle coupling portion (C3') may protrude from the plate (113') toward the inside of the container (111'). The first needle coupling portion (C1'), the second needle coupling portion (C2'), and the third needle coupling portion (C3') may be disposed on the first plate surface (1131'). The first needle coupling portion (C1') may be disposed in the first opening (O1') opposite to the first annular protrusion (P1'). The second needle coupling portion (C2') may be positioned in the second opening (O2') opposite the second annular protrusion (P2'). The third needle coupling portion (C3') may be positioned in the third opening (O3') opposite the third annular protrusion (P3').

[0115] The first plug (114A') can open and close the first opening (O1'). The second plug (114B') can open and close the second opening (O2'). The third plug (114C') can open and close the third opening (O3'). The first plug (114A'), the second plug (114B'), and the third plug (114C') may each include a coupling member (1141') capable of being coupled to an external unit such as a syringe, and a sealing member (1142') capable of substantially opening and closing each opening. The first plug (114A') may be coupled to the first annular protrusion (P1'). The second plug (114B') may be coupled to the second annular protrusion (P2'). The third plug (114C') can be coupled to the third annular protrusion (P3').

[0116] The sealing member (1142') may be formed of a flexible material such as silicone. Thus, when the coupling member (1141') of each plug is coupled with an external unit, the sealing member (1142') may be deformed so that each opening can be opened. Additionally, when the coupling member (1141') of each plug is separated from the external unit, the deformed sealing member (1142') returns to its state prior to deformation, and each opening can be closed again.

[0117] The sealing cap (115A') and sealing ring (115B') can seal between the plate (113') and the control portion (137') of the manipulator (130') described later. The fourth annular protrusion (P4') can surround a portion of the shaft (1371') of the control portion (137'), and the sealing cap (115A') and sealing ring (115B') can be placed between the fourth annular protrusion (P4') and the shaft (1371').

[0118] The piston guide (116') may be configured to prevent rotation of the piston (120'). Additionally, the piston guide (116') may guide the movement of the piston (120'). The piston guide (116') may have a cylindrical shape. The piston guide (116') may wrap around the fourth opening (O4') and extend toward the inside of the container (111') (i.e., toward the sealed space of the housing (110'). The piston guide (116') may be positioned on the first plate surface (1131'). The piston guide (116') may be positioned deflected with respect to the central axis (C-C').

[0119] The check valve (117') blocks the inflow of fluid (e.g., air) from the outside of the container (111') into the inside of the container (111'), but allows the fluid contained in the container (111') to flow out of the container (111'). The check valve (117') may be positioned around the sealing plate (113'). The check valve (117') may be positioned in the fifth opening (O5'). The check valve (117') may be coupled to the fifth annular protrusion (P5').

[0120] The piston (120') can be accommodated inside the container (111') of the housing (110'). The piston (120') can be configured to be movable along the longitudinal direction of the container (111'). That is, the piston (120') can move along the inner surface of the container (111') in the axial direction of the central axis (C-C'). The piston (120') may include an outer body (121'), an inner body (122'), a first partition (123A'), a second partition (123B'), a fluid passage (124'), and a piston sealing ring (125'). The outer body (121') may be a part of the piston (120') that moves along the longitudinal direction of the container (111'). The outer body (121') may be in contact with the container (111'). The inner body (122') may be located inside the outer body (121'). The inner body (122') can be connected to the outer body (121') and can move along the length direction of the container (111') together with the outer body (121').

[0121] The outer body (121') and the inner body (122') may each have a cylindrical shape having an open upper end and a lower end. The inner body (122') may be placed in the first partition (123A'). Specifically, the lower end of the inner body (122') may be connected to the first partition (123A'). The inner body (122') may be located inside the piston guide (116') and thus may be positioned deflected with respect to the central axis (C-C'). At least a portion of the outer surface of the inner body (122') may substantially contact at least a portion of the inner surface of the piston guide (116'). The open upper end of the inner body (122') and the open upper end of the outer body (121') may be substantially the same. Since the inner diameter of the piston guide (116') is substantially the same as the outer diameter of the inner body (122'), the piston guide (116') wraps around the inner body (122') while substantially contacting the inner body (122') (i.e., at least a portion of the inner surface of the piston guide (116') substantially contacts at least a portion of the outer surface of the inner body (122'), and the open upper end of the inner body (122') and the open upper end of the outer body (121') are substantially the same, the inner body (122') can prevent materials located in the first space (S1'), the second space (S2'), and the third space (S3') from contacting the shaft (1371'), male engagement element (1372'), and female engagement element (137'3) located within the inner body (122'). As a result, the rotation of the shaft (1371') may not affect the materials located in the first space (S1'), the second space (S2'), and the third space (S3').Additionally, the outer diameter of the inner body (122') and the inner diameter of the piston guide (116') are substantially the same, so that the inner body (122') and the piston guide (116') are substantially in contact, and the inner body (122') and the piston guide (116') are positioned biased with respect to the central axis (C-C'), so that when the piston (120') moves in the axial direction of the central axis (C-C'), the inner body (122') of the piston (120') can move along the piston guide (116') and rotation is prevented.

[0122] The inner body (122') may include a first longitudinal section (1221') having a first inner diameter and a second longitudinal section (1222') connected to the first longitudinal section (1221') and having a second inner diameter. The outer diameters of the first longitudinal section (1221') and the second longitudinal section (1222') may be the same, and the second inner diameter may be smaller than the first inner diameter. Thus, a step may be formed between the first longitudinal section (1221') and the second longitudinal section (1222').

[0123] The first partition (123A') can be connected to the lower end of the outer body (121') and the inner body (122'), and can be connected to the upper end of the fluid passage (124'). Since the diameter of the fluid passage (124') is smaller than the diameter of the outer body (121'), the first partition (123A') may have a truncated cone shape with a diameter decreasing in the direction away from the outer body (121') along the axial direction of the central axis (C-C'), and thus may have inclined sides. Additionally, the lower end of the inner body (122') connected to the first partition (123A') may be inclined. The first partition (123A') may include a shaft hole (H1') connected to the open lower end of the inner body (122').

[0124] The outer body (121'), the inner body (122'), and the first partition (123A') may define a first space (S1') in a sealed space of the housing (110'). For example, the first space (S1') may be defined as a space enclosed by the inner side of the outer body (121'), the outer side of the inner body (122'), and the inner side of the first partition (123A').

[0125] The second partition (123B') may be connected to the lower end of the fluid passage (124'). The second partition (123B') may have a truncated cone shape with a diameter increasing in the direction away from the outer body (121') along the axial direction of the central axis (C-C'). The second partition (123B') may include an inclined portion (123B'-2) connected to the lower end of the fluid passage (124') and a flat portion (123B'-1) connected to the inclined portion (123B'-2) and substantially flat.

[0126] The container (111'), the second partition (123B'), and the piston seal ring (125') can define a second space (S2') in the enclosed space of the housing (110'). For example, the second space (S2') can be defined as a space enclosed by the inner side of the container (111'), the inner side of the second partition (123B'), and the outer side of the piston seal ring (125').

[0127] The fluid passage (124') may have a cylindrical shape connecting the first partition (123A') and the second partition (123B'). The space enclosed by the inner side of the fluid passage (124') may be defined as a third space (S3'). The fluid passage (124') may include an open upper end and a lower end, and thus the third space (S3') may be fluidly connected to the first space (S1') and the second space (S2') and may have a target material located therein.

[0128] The piston sealing ring (125') can be placed in a recess formed on the side of the flat portion (123B'-1). The piston sealing ring (125') can maintain a seal between the piston (120') and the container (111').

[0129] The manipulator (130') can move the piston (120') relative to the housing (110'). The manipulator (130') can be operably coupled to the piston (120'). Here, "operably coupled" means that the manipulator (130') directly drives the piston (120'). The manipulator (130') may include a handle (131'), a pair of engaging members (136A', 136B'), and a control member (137').

[0130] The handle (131') may be configured to be operated by a user. Here, in addition to being operated by a person, the handle (131') may be operated by a mechanical and / or electrical mechanism. The handle (131') may include a base (132') and a side (133A') connected to the base (132'), and may have a substantially cylindrical shape. The handle (131') may include an inner space (134') defined by the base (132') and the side (133A'). A plurality of recesses (133B') may be arranged on the side (133A') of the handle (131'), extending in the axial direction of the central axis (C-C') and formed along the circumferential direction of the handle (131'). By means of a plurality of concave portions (133B'), the gripping force is increased when the user grasps the handle (131') to operate the handle (131'), allowing the handle (131') to be operated with less force. Additionally, the handle (131') may include a hollow protrusion (135') that protrudes from the base (132') toward the inner space (134'), and the hollow protrusion (135') may receive a first plug (114A').

[0131] The handle (131') can be rotatably coupled to the housing (110'). Additionally, the handle (131') can be removablely coupled to the housing (110').

[0132] A pair of interlocking members (136A', 136B') may include a first interlocking member (136A') formed on the side of the hollow protrusion (135') and a second interlocking member (136B') operably connected to the adjustment member (137'). The first interlocking member (136A') and the second interlocking member (136B') may be operably interlocked with each other. When a user rotates the handle (131'), the first interlocking member (136A') formed around the hollow protrusion (135') of the handle (131') also rotates together, and as a result, the second interlocking member (136B') engaged with the first interlocking member (136A') rotates, thereby allowing the adjustment member (137') to be operated.

[0133] The adjustment unit (137') can finely adjust the movement of the piston (120'). Additionally, the adjustment unit (137') can fix the piston (120') in place. The adjustment unit (137') may include a shaft (1371'), a male engagement element (1372'), and a female engagement element (1373').

[0134] The shaft (1371') has a rotation axis (R-R') and can rotate about the rotation axis (R-R'). The adjustment part (137') can rotate about the rotation axis (R-R') by the rotation of the shaft (1371'). The shaft (1371') may include a coupling part (1375') in which a head (1374') installed on the plate (113') and a second engaging member (136B') are disposed. The head (1374') is disposed on the upper surface of the plate (113'), and a sealing cap (115A') and a sealing ring (115B') may be disposed between the head (1374') and the second annular protrusion (P2'). The connecting portion (1375') is a portion located above the head (1374') and above the sealing cap (115A'), which can define the top of the shaft (1371'). The shaft (1371') may be located at least partially within the inner body (122'). The inner body (122') and the piston guide (116') can prevent the rotational force of the shaft (1371') from being transmitted to materials located in the first space (S1'), the second space (S2'), and the third space (S3') when the shaft (1371') rotates.

[0135] The male engagement element (1372') is formed along the axial direction of the rotation axis (R-R') of the shaft (1371') and may have a predetermined pitch. The male engagement element (1372') may be formed spirally on the portion of the shaft (1371') located below the plate (113'). The shaft (1371') and the male engagement element (1372') can be understood as forming a rigid screw structure. The female engagement element (1373') engages with the male engagement element (1372') and may have a pitch corresponding to the pitch of the male engagement element (1372'). The female engagement element (1373') can be understood as forming a nut structure. The pitch of the male engagement element (1372') and the pitch of the female engagement element (1373') can be determined based on the user's handle (131') rotation angle and the travel distance of the piston (120'). Additionally, if the pitch is too large, the shaft (1371') may rotate and the piston (120') may move due to the force applied to the piston by an external force (e.g., centrifugal force). Therefore, the pitch can be determined within an appropriate range so that the shaft (1371') does not rotate due to the external force while minimizing the operation of the handle (131').

[0136] The arm engagement element (1373') can be formed on the inner surface of the first longitudinal portion (1221') of the piston (120'). Accordingly, the arm engagement element (1373') can move together with the piston (120').

[0137] The mutual interlocking of the male interlocking element (1372') and the female interlocking element (1373') as described above enables the user to fix the piston (120') at a desired position while ensuring the movement of the piston (120').

[0138] The inner body (122') and the piston guide (116') are configured so that when the shaft (1371') rotates and the regulating part (137') rotates, the rotational force of the regulating part (137') is not transmitted to the material located in the first space (S1'), the second space (S2'), and the third space (S3'), and the regulating part (137') are isolated so that the material located in the first space (S1'), the second space (S2'), and the third space (S3') and the regulating part (137') do not come into contact with each other.

[0139] The first needle (140A') may be configured to inject the fluid to be separated by the body fluid component separation device (10') into the container. Additionally, the first needle (140A') may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10') to the outside of the container (111'). The first needle (140A') may be at least partially accommodated in the sealed space of the housing (110'). The first needle (140A') may include a needle upper portion (141') and a needle lower portion (142').

[0140] The needle upper portion (141') can be inserted at least partially into the first opening (O1'). Thus, the needle upper portion (141') can be accommodated at least partially in the sealed space of the housing (110'). The needle upper portion (141') can be fixed in position relative to the housing (110'), particularly relative to the lead (112'), by being coupled to the first needle coupling portion (C1'). The needle upper portion (141') may have a cylindrical shape having an open upper end and a lower end.

[0141] The lower needle (142') may overlap at least partially with the upper needle (141'). The lower needle (142') may be connected to the piston (120') by a needle support (150') to be described later, and thus configured to be movable relative to the upper needle (141') by the movement of the piston (120'). The lower needle (142') may have a cylindrical shape having an open upper end and an open lower end.

[0142] In one embodiment, the outer diameter of the upper needle (141') may be larger than the outer diameter of the lower needle (142'). The inner diameter of the upper needle (141') may be substantially the same as the outer diameter of the lower needle (142'). The lower needle (142') may be inserted at least partially into the upper needle (141'). Since the inner diameter of the upper needle (141') is substantially the same as the outer diameter of the lower needle (142'), the lower needle (142') can move smoothly relative to the upper needle (141'), and prevent fluid passing through the first needle (140A') from leaking out of the first needle (140A') through the space between the upper needle (141') and the lower needle (142').

[0143] In one embodiment, the outer diameter of the lower needle (142') may be larger than the outer diameter of the upper needle (141'). The inner diameter of the lower needle (142') may be substantially the same as the outer diameter of the upper needle (141'). The upper needle (141') may be inserted at least partially into the lower needle (142'). Since the inner diameter of the lower needle (142') is substantially the same as the outer diameter of the upper needle (141'), the lower needle (142') can move smoothly relative to the upper needle (141'), and prevent fluid passing through the first needle (140A') from leaking out of the first needle (140A') through the space between the upper needle (141') and the lower needle (142').

[0144] The second needle (140B') may be configured to inject the fluid to be separated by the body fluid component separation device (10') into the container. Additionally, the second needle (140B') may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10') to the outside of the container (111'). The second needle (140B') may be at least partially accommodated in the sealed space of the housing (110').

[0145] The second needle (140B') can be inserted into the second opening (O2'). Thus, the second needle (140B') can be accommodated at least partially in the sealed space of the housing (110'). The second needle (140B') can maintain a fixed position relative to the housing (110'), particularly relative to the lead (112'), by being coupled to the second needle coupling portion (C2'). The second needle (140B') may have a cylindrical shape having an open upper end and a lower end. The lower end of the second needle (140B') may be located in the first space (S1').

[0146] In one embodiment, the second needle (140B') may be inserted into the third opening (O3') instead of the second opening (O2') and may be coupled to the third needle coupling part (C3').

[0147] In one embodiment, the body fluid component separation device (10') may further include a third needle (not shown). In this embodiment, the second needle (140B') may be inserted into the second opening (O2'), and the third needle may be inserted into the third opening (O3'). The third needle may have a cylindrical shape having an open upper end and a lower end, and the lower end of the third needle may be located in the first space (S1').

[0148] The needle support (150') can connect the first needle (140A') and the piston (120') to each other. Specifically, it can connect the needle lower portion (142') of the first needle (140A') and the inner body (122') of the piston (120') to each other. The needle support (150') may include a support body (151') and a support arm (152'). The support body (151') may be connected to the needle lower portion (142'). The support body (151') may have a sleeve shape that wraps around the needle lower portion (142') of the first needle (140A'). The needle lower portion (142') may be inserted into the needle hole (1511') of the support body (151'). The support arm (152') can connect the support body (151') and the inner body (122') of the piston (120') to each other and can fix the position of the needle lower part (142') relative to the piston (120').

[0149] The body fluid component separation device (10') can be used to separate PRP from blood, in which case PRP becomes the target substance. After one centrifugation using the body fluid component separation device (10'), the blood can be separated into plasma, PRP, and red blood cells. Before performing centrifugation using the body fluid component separation device (10'), the user can set the position of the piston (120') by operating the handle (131') so that the PRP (target substance) after centrifugation is located in the third space (S3') according to the amount of blood to be centrifuged. After centrifugation is performed, the user can further fine-tune the position of the piston (120') by removing the handle (131') and operating the second engaging member (136B') so that the PRP (target substance) is located at the lower end of the needle lower part (142'). Additionally, by means of a needle support (150') that fixes the lower part of the needle (142') and connects it to the piston (120'), the position of the lower end of the lower part of the needle (142') can be fixed in the third space (S3') even if the position of the piston (120') moves (i.e., even if the piston (120') moves substantially up and down along the longitudinal direction of the housing (110'). As previously mentioned, since the container (111') is formed of a substantially transparent material or a substantially translucent material, the user can visually check the target substances of the fluid separated inside the container after centrifugation, and can move the piston (120') so that each substance is received in the first space (S1'), the second space (S2'), and the third space (S3') before and after centrifugation by only operating the handle (131') and the second interlocking member (136B').

[0150] After centrifugation, an external unit such as a syringe can be attached to the first plug (114A'), and the PRP (target substance) contained in the third space (S3') can be first extracted to the outside of the body fluid component separation device (10') through the first needle (140A'), and then the substance contained in the first space (S1') can be extracted to the outside of the body fluid component separation device (10') through the second needle (140B'). Alternatively, the substance contained in the first space (S1') can be first extracted to the outside of the body fluid component separation device (10') through the second needle (140B'), and then the PRP (target substance) contained in the third space (S3') can be extracted to the outside of the body fluid component separation device (10') through the first needle (140A').

[0151] In the case of centrifuging a body fluid such as blood, where the layer containing the target substance is located in the center after centrifugation, the target substance can be extracted from the body fluid component separation device (10') through a needle lower part (142') having a lower end that is always fixed in the third space (S3') located in the center. Thus, the target substance can be extracted with only one centrifugation.

[0152] Although the embodiments of the present invention described above have been described in relation to an embodiment for centrifuging a body fluid in which the layer containing the target substance is located in the center after centrifugation, and the amount of the target substance is relatively small compared to the amount of other substances, it should be understood that the present invention may also be applied to a body fluid in which the target substance is located in a layer other than the center layer and the amount of the target substance is relatively large compared to the amount of other substances. For example, in an embodiment not illustrated, the lower end of the needle lower (142') may be located in the second space (S2'), and the needle support (150') may be connected to the outer body (121') instead of the inner body (122') of the piston (120').

[0153] Referring to FIGS. 11 to 18, the body fluid component separation device (10) can separate a target substance from a body fluid to be separated. For example, platelet-rich plasma (PRP) can be separated from blood. The body fluid component separation device (10) can receive a body fluid and separate the received body fluid into multiple layers using centrifugation. For example, when blood is centrifuged, the body fluid component separation device (10) can be configured to extract PRP from the buffy coat layer among the multiple layers.

[0154] The body fluid component separation device (10) may include a housing (110)), a piston (120)), a manipulator (130)), a first needle (140A) and a second needle (140B).

[0155] The housing (110) may accommodate at least a portion of the piston (120), the manipulator (130), at least a portion of the first needle (140A) and at least a portion of the second needle (140B). The housing (110) may include a container (111) and a lid (112). The container (111) and the lid (112) may define a sealed space with respect to the outside of the housing (110). The sealed space of the housing (110) defined by the container (111) and the lid (112) may include a first space (S1), a second space (S2), and a third space (S3).

[0156] The container (111) may have a cylindrical shape with a central axis (C-C'). Additionally, the container (111) may have an open upper end, a closed side, and a closed lower end. The container (111) may have a recessed step (111A) in the radial direction of the container (111) at the open upper end.

[0157] The container (111) may be formed of a substantially transparent material or a substantially translucent material so that the interior of the container (111) can be seen from the outside of the container (111). The user can check the amount of body fluid to be separated present inside the container (111), and the movement of substances in the body fluid separated into multiple layers.

[0158] The lid (112) can seal the open upper end of the container (111). The lid (112) may include a plate (113), a first plug (114A), a second plug (114B), a third plug (114C), a sealing cap (115A), a sealing ring (115B), a piston guide (116), and a check valve (117).

[0159] The plate (113) may cover the open upper end of the container (111). Corresponding to the cylindrical container (111), the plate (113) may have a substantially disc shape. The plate (113) may be joined to the step (111A) of the container (111) at the open upper end of the container (111). The plate (113) may include a first plate surface (1131) facing the enclosed space of the housing, and a second plate surface (1132) opposite to the first plate surface (1131).

[0160] The plate (113) may include a first opening (O1), a second opening (O2), a third opening (O3), a fourth opening (O4), and a fifth opening (O5). The first opening (O1), the second opening (O2), the third opening (O3), the fourth opening (O4), and the fifth opening (O5) may penetrate the plate (113) from the first plate surface (1131) to the second plate surface (1132). For example, the first opening (O1"), the second opening (O2"), the third opening (O3"), the fourth opening (O4"), and the fifth opening (O5") may penetrate the plate (113") in the thickness direction of the plate (113"). The first opening (O1"), the second opening (O2"), the third opening (O3"), the fourth opening (O4"), and the fifth opening (O5") may have a substantially circular shape. The first opening (O1") may be located at the center of the plate (113"). The center of the plate (113") may be defined as a part of the plate (113") that includes a central axis (C-C'). The second opening (O2), the third opening (O3), the fourth opening (O4), and the fifth opening (O5) may be located at the periphery of the plate (113). The periphery of the plate (113) may be defined as the part of the plate (113) that surrounds the center of the plate (113). The second opening (O2), the third opening (O3), the fourth opening (O4), and the fifth opening (O5) may be arranged circumferentially along the periphery of the plate (113). In one embodiment, the size (e.g., diameter) of each of the first opening (O1), the second opening (O2), the third opening (O3), the fourth opening (O4), and the fifth opening (O5) may be different from one another. In one embodiment, the sizes (e.g., diameters) of two or more of the first opening (O1"), the second opening (O2"), the third opening (O3"), the fourth opening (O4"), and the fifth opening (O5") may be the same as each other.

[0161] The plate (113) may include a first annular protrusion (P1), a second annular protrusion (P2), a third annular protrusion (P3), a fourth annular protrusion (P4), and a fifth annular protrusion (P5). The first annular protrusion (P1"), the second annular protrusion (P2"), the third annular protrusion (P3"), the fourth annular protrusion (P4"), and the fifth annular protrusion (P5") can serve as supports that allow other components (e.g., the first plug (114A"), etc.) that are coupled to or placed on the lead (112") (or plate (113") to be securely fixed to the lead (112"). The first annular protrusion (P1"), the second annular protrusion (P2"), the third annular protrusion (P3"), the fourth annular protrusion (P4"), and the fifth annular protrusion (P5") may protrude from the plate (113") in a direction away from the container (111"). The first annular protrusion (P1"), the second annular protrusion (P2"), the third annular protrusion (P3"), the fourth annular protrusion (P4"), and the fifth annular protrusion (P5") may be disposed on the second plate surface (1132"). The first annular protrusion (P1") may be disposed in the first opening (O1"), the second annular protrusion (P2") may be disposed in the second opening (O2"), the third annular protrusion (P3") may be disposed in the third opening (O3"), the fourth annular protrusion (P4") may be disposed in the fourth opening (O4"), and the fifth annular protrusion (P5") may be disposed in the fifth opening (O5"). In one embodiment, the shapes of the first annular protrusion (P1"), the second annular protrusion (P2"), the third annular protrusion (P3"), the fourth annular protrusion (P4"), and the fifth annular protrusion (P5") may be different from each other.In one embodiment, the shapes of two or more of the annular protrusions among the first annular protrusion (P1"), the second annular protrusion (P2"), the third annular protrusion (P3"), the fourth annular protrusion (P4"), and the fifth annular protrusion (P5") may be identical to each other.

[0162] The plate (113) may include a first needle coupling portion (C1) and a second needle coupling portion (C2). The first needle coupling portion (C1) and the second needle coupling portion (C2) may protrude from the plate (113) toward the inside of the container (111). The first needle coupling portion (C1) and the second needle coupling portion (C2) may be positioned on the first plate surface (1131). The first needle coupling portion (C1) may be positioned in the first opening (O1) opposite to the first annular protrusion (P1). The second needle coupling portion (C2) may be positioned in the second opening (O2) opposite to the second annular protrusion (P2). The first needle coupling portion (C1") can allow the first needle (140A"), in particular the needle fixing portion (141") of the first needle (140A"), to be stably positioned with respect to the lead (112") (or plate (113")). The second needle coupling portion (C2") can allow the second needle (140B") to be stably positioned with respect to the lead (112") (or plate (113")).

[0163] In one embodiment, the plate (113") may include a third needle coupling portion. The third needle coupling portion may protrude from the plate (113") toward the inside of the container (111") and may be positioned on the first plate surface (1131"). The third needle coupling portion may be positioned in the third opening (O3") opposite to the third annular protrusion (P3").

[0164] The first plug (114A) can open and close the first opening (O1). The second plug (114B) can open and close the second opening (O2). The third plug (114C) can open and close the third opening (O3). The first plug (114A) can be coupled to the first annular protrusion (P1). The second plug (114B) can be coupled to the second annular protrusion (P2). The third plug (114C) can be coupled to the third annular protrusion (P3). The first plug (114A"), the second plug (114B"), and the third plug (114C") may each include a coupling member (1141") that can be coupled with an external unit such as a syringe, and a sealing member (1142") that can substantially open and close each opening.

[0165] The sealing member (1142) may be formed of a flexible material such as silicone. Thus, when the coupling member (1141) of each plug is coupled with the external unit, the sealing member (1142) may be deformed so that each opening can be opened. Additionally, when the coupling member (1141) of each plug is separated from the external unit, the deformed sealing member (1142) returns to its state before deformation, and each opening can be closed again.

[0166] The sealing cap (115A) and sealing ring (115B) can seal between the plate (113) and the control portion (137) of the manipulator (130) described later. The fourth annular protrusion (P4) can surround a portion of the shaft (1371) of the control portion (137), and the sealing cap (115A) and sealing ring (115B) can be placed between the fourth annular protrusion (P4) and the shaft (1371).

[0167] The piston guide (116) may be configured to prevent rotation of the piston (120). Additionally, the piston guide (116) may guide the movement of the piston (120) (i.e., movement along the longitudinal direction of the container (111)). The piston guide (116) may have a cylindrical shape. The piston guide (116) may wrap around the fourth opening (O4) and extend toward the inside of the container (111) (i.e., toward the sealed space of the housing (110)). The piston guide (116) may be positioned on the first plate surface (1131). The piston guide (116) may be positioned deflected with respect to the central axis (C-C') (i.e., on the periphery of the plate (113)).

[0168] The check valve (117) blocks the inflow of fluid (e.g., air) from the outside of the container (111) into the inside of the container (111), but allows the fluid contained in the container (111) to flow out of the container (111). The check valve (117) may be positioned around the periphery of the sealing plate (113). The check valve (117) may be positioned in the fifth opening (O5). The check valve (117) may be coupled to the fifth annular projection (P5).

[0169] The piston (120) can be accommodated inside the container (111) of the housing (110). The piston (120) can be configured to be movable along the longitudinal direction of the container (111). That is, the piston (120) can move along the inner side of the container (111) in the axial direction of the central axis (C-C'). The piston (120) may include an outer body (121), an inner body (122), a partition (123), an indicator (124), and a piston sealing ring (125).

[0170] The outer body (121) may be a part of the piston (120) that moves along the longitudinal direction of the container (111). The outer body (121) may come into contact with the container (111). That is, the outer surface of the outer body (121) may come into contact with the inner surface of the container (111).

[0171] The inner body (122) may be located inside the outer body (121). The inner body (122) may be connected to the outer body (121) by a partition (123) and may move along the length direction of the container (111) together with the outer body (121).

[0172] The outer body (121) and the inner body (122) may each have a substantially cylindrical shape. The lower end of the outer body (121) and the lower end of the inner body (122) may each be connected to a partition (123). The upper end of the outer body (121) and the upper end of the inner body (122) may be substantially the same. The upper end of the outer body (121) and the upper end of the inner body (122) may be located at substantially the same position relative to the container (111). The upper end of the outer body (121) and the upper end of the inner body (122) may be located at substantially the same position along the longitudinal direction of the container (111).

[0173] A substantially annular space may be defined between the outer body (121) and the inner body (122). The annular space between the outer body (121) and the inner body (122) may be part of the first space (S1). A piston guide (116) may be placed in the annular space between the outer body (121) and the inner body (122). In one embodiment, the outer surface of the piston guide (116) may be in substantial contact with at least a portion of the inner surface of the outer body (121).

[0174] The inner body (122") can be positioned inside the piston guide (116") and thus positioned biased with respect to the central axis (C-C'). At least a portion of the outer surface of the inner body (122") can substantially contact at least a portion of the inner surface of the piston guide (116").

[0175] Since the inner diameter of the piston guide (116) is substantially the same as the outer diameter of the inner body (122) so that the piston guide (116) substantially contacts the inner body (122) (i.e., at least a portion of the inner surface of the piston guide (116) substantially contacts at least a portion of the outer surface of the inner body (122)) and surrounds the inner body (122), and because the open upper end of the inner body (122) and the open upper end of the outer body (121) are substantially the same, the inner body (122) can prevent materials located in the first space (S1), the second space (S2), and the third space (S3) from contacting the shaft (1371), male engagement element (1372), and female engagement element (1373) located within the inner body (122). Consequently, rotation of the shaft (1371) in the first space (S1), the second space (S2), and the third It may not affect materials located in space (S3). Additionally, the outer diameter of the inner body (122) and the inner diameter of the piston guide (116) are substantially the same, so that the inner body (122) and the piston guide (116) are substantially in contact, and the inner body (122) and the piston guide (116) are positioned biased with respect to the central axis (C-C'), so that when the piston (120) moves in the axial direction of the central axis (C-C'), the inner body (122) of the piston (120) can move along the piston guide (116) and rotation is prevented.

[0176] The inner body (122) may include a first longitudinal section (1221) having a first inner diameter and a second longitudinal section (1222) connected to the first longitudinal section (1221) and having a second inner diameter. The outer diameters of the first longitudinal section (1221) and the second longitudinal section (1222) may be the same, and the second inner diameter may be smaller than the first inner diameter. Thus, a step may be formed between the first longitudinal section (1221) and the second longitudinal section (1222).

[0177] A partition (123) can connect an outer body (121) and an inner body (122). The partition (123) can separate the enclosed space of the housing (110) defined by the container (111) and the lid (112) into a first space (S1) and a second space (S2). The partition (123) can connect the lower end of the outer body (121) and the lower end of the inner body (122). The partition (123) may have a truncated cone shape with a diameter that decreases from the outside inward, at least partially.

[0178] The partition (123) may include a groove (1231) for accommodating at least one material in the first space (S1). The groove (1231) is formed at the lowest position of the substantially inclined partition (123), and thus the groove (1231) may define the space at the lowest position in the first space (S1), and when the material accommodated in the first space (S1) is distinguished into multiple layers, the component of the layer accommodated in the groove (1231) may have a higher specific gravity than the component of the layer not accommodated in the groove (1231). The groove (1231) may have a shape that narrows in width along the thickness direction of the partition (123).

[0179] The partition (123) may also include a sealing recess (1232) formed radially to the piston (120). A piston sealing ring (125) may be placed in the sealing recess (1232).

[0180] The indicator (124) may include a third space (S3) that fluidly communicates with the first space (S1) and the second space (S2). Accordingly, the indicator (124") can be understood as a fluid passage fluidly communicating with the first space (S1") and the second space (S2"). The indicator (124") may include a first indicator end (1241") and a second indicator end (1242") opposite to the first indicator end (1241"). The first indicator end (1241") may be the lower end of the indicator (124"), and the second indicator end (1242") may be the upper end of the indicator (124"). The first indicator end (1241") and the second indicator end (1242") may each be open to allow fluid movement between the first space (S1") and the second space (S2"). The indicator (124") is the first indicator It may be connected to a partition (123) at an end (1241). The indicator (124) may have a cylindrical structure extending between the first indicator end (1241) and the second indicator end (1242). The length of the indicator (124) may be equal to or smaller than the length of the outer body (121) and the inner body (122). The indicator (124) may include an indicator wall (1243) located between the first indicator end (1241) and the second indicator end (1242). The indicator wall (1243) may include an indicator outer surface (1243A) and an indicator inner surface (1243B) opposite to the indicator outer surface (1243A). In one embodiment, the outer surface of the piston guide (116") may substantially contact at least a portion of the outer surface of the indicator (1243A").

[0181] The indicator (124) may be configured to indicate a predetermined fluid flowing between the first space (S1) and the second space (S2), including a third space (S3) that is smaller than the first space (S1) and the second space (S2). The statement that the indicator (124) "indicates a fluid" can be understood as visualizing to the user the amount and flow of the buffy coat layer containing PRP among a plurality of layers separated by a predetermined process (e.g., centrifugation).

[0182] The piston sealing ring (125) is joined to the sealing recess (1232) and can maintain a seal between the piston (120) and the container (111).

[0183] The lid (112"), outer body (121"), inner body (122"), partition (123"), and indicator (124") can define a first space (S1") in a sealed space of the housing (110"). For example, the first space (S1") can be defined as a space enclosed by the first plate surface (1131") of the plate (113") of the lid (112"), the inner surface of the container (111"), the inner surface of the outer body (121"), the outer surface of the inner body (122"), the upper surface of the partition (123"), and the outer surface (1243A") of the indicator. For example, the first space (S1") can be defined as an upper space of the container (111") separated by the partition (123").

[0184] The container (111)), partition (123) and piston seal ring (125) can define a second space (S2) in the enclosed space of the housing (110). For example, the second space (S2) can be defined as a space enclosed by the inner surface of the container (111) and the lower surface of the partition (123) and the outer surface of the piston seal ring (125). For example, the second space (S2) can be defined as a lower space of the container (111) separated by the partition (123).

[0185] A third space (S3) fluidly communicating with the first space (S1) and the second space (S2) can be defined by an indicator (124). For example, the third space (S3) can be defined as a space enclosed by the inner surface (1243B) of the indicator wall (1243) of the indicator (124).

[0186] The manipulator (130) can move the piston (120) relative to the housing (110). The manipulator (130) can be operably coupled to the piston (120). Here, "operably coupled" means that the manipulator (130) directly drives the piston (120). The manipulator (130) may include a handle (131), a pair of engaging members (136A, 136B), and a control unit (137).

[0187] The handle (131) may be configured to be operated by a user. Here, in addition to being operated by a person, the handle (131) may be operated by a mechanical and / or electrical mechanism. The handle (131) may include a base (132) and a side (133A) connected to the base (132), and may have a substantially cylindrical shape. The handle (131) may include an inner space (134) defined by the base (132) and the side (133A). A plurality of recesses (133B) may be arranged on the side (133A) of the handle (131) that extend in the axial direction of the central axis (C-C') and are formed along the circumferential direction of the handle (131). By means of the plurality of recesses (133B), the gripping force is increased when the user grasps the handle (131) to operate the handle (131), allowing the handle (131) to be operated with less force. Additionally, the handle (131) may include a hollow protrusion (135) that protrudes from the base (132) toward the inner space (134), and the hollow protrusion (135) may receive a first plug (114A).

[0188] The handle (131) can be rotatably coupled to the housing (110). Additionally, the handle (131) can be removablely coupled to the housing (110).

[0189] A pair of interlocking members (136A", 136B") may include a first interlocking member (136A") formed on the side of the hollow protrusion (135") and a second interlocking member (136B") operably connected to the adjustment member (137"). The first interlocking member (136A") and the second interlocking member (136B") may be operably interlocked with each other. When a user rotates the handle (131"), the first interlocking member (136A") formed around the hollow protrusion (135") of the handle (131") also rotates together, and thereby the second interlocking member (136B") engaged with the first interlocking member (136A") rotates, and the adjustment member (137") may be operated.

[0190] The adjustment unit (137) can finely adjust the movement of the piston (120). Additionally, the adjustment unit (137) can fix the piston (120) in place. The adjustment unit (137) may include a shaft (1371), a male engagement element (1372), and a female engagement element (1373).

[0191] The shaft (1371) has a rotation axis (R-R') and can rotate about the rotation axis (R-R'). The adjustment part (137) can rotate about the rotation axis (R-R') by the rotation of the shaft (1371). The shaft (1371) may include a head (1374) installed on the plate (113) and a coupling part (1375) on which a second engaging member (136B) is disposed. The head (1374) is disposed on the upper surface of the plate (113), and a sealing cap (115A) and a sealing ring (115B) may be disposed between the head (1374) and the second annular protrusion (P2). The coupling part (1375) may define the upper end of the shaft (1371) as a part located above the head (1374) and above the sealing cap (115A). The shaft (1371) can be located at least partially within the inner body (122).

[0192] The male engagement element (1372) is formed along the axial direction of the rotation axis (R-R') of the shaft (1371) and may have a predetermined pitch. The male engagement element (1372) may be formed spirally on the portion of the shaft (1371) located below the plate (113). The shaft (1371) and the male engagement element (1372) can be understood as forming a rigid screw structure. The female engagement element (1373) engages with the male engagement element (1372) and may have a pitch corresponding to the pitch of the male engagement element (1372). The female engagement element (1373) can be understood as forming a nut structure. The pitch of the male engagement element (1372) and the pitch of the female engagement element (1373) can be determined based on the user's rotational angle of the handle (131) and the travel distance of the piston (120). Additionally, if the pitch is too large, the shaft (1371) may rotate and the piston (120) may move due to the force applied to the piston by an external force (e.g., centrifugal force); therefore, the pitch can be determined within an appropriate range so that the shaft (1371) does not rotate due to the external force while minimizing the operation of the handle (131).

[0193] The arm engagement element (1373) can be received and mounted in the cavity of the first longitudinal portion (1221) of the piston (120). Accordingly, the arm engagement element (1373) can move together with the piston (120). The range of movement of the arm engagement element (1373) may be limited by a step between the first longitudinal portion (1221) and the second longitudinal portion (1222). In one embodiment, the arm engagement element (1373) may include a projection that can be firmly fixed to the inner body (122) of the piston (120).

[0194] The mutual interlocking of the first interlocking member (136A) and the second interlocking member (136B) as described above, and the mutual interlocking of the male interlocking element (1372) and the female interlocking element (1373), enable the user to fix the piston (120) at a desired position while ensuring the movement of the piston (120).

[0195] The inner body (122) and the piston guide (116) are configured so that when the shaft (1371) rotates and the regulating part (137) is actuated, the rotational force of the shaft (1371) is not transmitted to the material located in the first space (S1), the second space (S2), and the third space (S3), and the material located in the first space (S1), the second space (S2), and the third space (S3) and the regulating part (137) can be isolated so that they do not come into contact with each other.

[0196] The first needle (140A") may be configured to inject the fluid to be separated by the body fluid component separation device (10") into the container (111"). Additionally, the first needle (140A") may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10") to the outside of the container (111"). The first needle (140A") may be at least partially accommodated in the sealed space of the housing (110"). The first needle (140A") may be at least partially accommodated in the first space (S1") and at least partially accommodated in the third space (S3"). The first needle (140A") may be positioned substantially coaxial with the central axis (C-C'). The first needle (140A") may include a needle fixing portion (141") and a needle moving portion (142"). The lower end of the first needle (140A") (i.e., the open portion through which material flows into the first needle (140A")) may be located in a third space (S3").

[0197] The needle fixing portion (141) can be inserted at least partially into the first opening (O1). Thus, the needle fixing portion (141) can be accommodated at least partially in the sealed space of the housing (110). The needle fixing portion (141) can be maintained in a fixed position relative to the housing (110), particularly relative to the lead (112), by being coupled to the first needle coupling portion (C1). The needle fixing portion (141) may have a cylindrical shape having an open upper end and a lower end.

[0198] The needle moving part (142) can be fixed to the piston (120). The needle moving part (142) can be connected to the inner surface (1243B) of the indicator wall (1243) of the indicator (124) by the needle support (150) described later, and thus configured to be movable relative to the needle fixed part (141) by the movement of the piston (120). The needle moving part (142) can overlap at least partially with the needle fixed part (141). The needle moving part (142) can accommodate at least a part of the needle fixed part (141). The needle fixed part (141) and the needle moving part (142) can be arranged coaxially with each other.

[0199] The outer diameter of the needle moving part (142) may be larger than the outer diameter of the needle fixed part (141). The inner diameter of the needle moving part (142) may be substantially the same as the outer diameter of the needle fixed part (141). The needle fixed part (141) may be inserted at least partially into the hollow of the needle moving part (142). Because the inner diameter of the needle moving part (142) is substantially the same as the outer diameter of the needle fixed part (141), the needle moving part (142) can move smoothly along the outer surface of the needle fixed part (141), and prevent fluid passing through the first needle (140A) from leaking out of the first needle (140A) through the space between the needle fixed part (141) and the needle moving part (142).

[0200] In one embodiment, the outer diameter of the needle moving portion (142) may be substantially the same as the inner diameter of the needle fixing portion (141). The needle moving portion (142) may be inserted at least partially into the hollow of the needle fixing portion (141). In this embodiment, the needle support (150) may not be positioned immediately adjacent to the second indicator end (1242), but may be positioned in any area along the longitudinal direction of the indicator (124) that does not overlap with the needle fixing portion (141).

[0201] The length of the needle moving portion (142) may be less than or equal to the length of the needle fixed portion (141). In one embodiment, when the piston (120) is in a position where it contacts the lead (112), the lower end of the needle fixed portion (141) may be lower than the lower end of the needle moving portion (142) (i.e., located further away from the lead (112)). In one embodiment, when the piston (120) is in a position where it contacts the lead (112), the lower end of the needle fixed portion (141) and the lower end of the needle moving portion (142) may be on the same plane.

[0202] The upper end of the needle moving part (142) may be located substantially on the same plane as the second indicator end (1242) of the indicator (124) (i.e., the upper end of the indicator (124)). The lower end of the needle moving part (142) (i.e., the open part through which material flows into the needle moving part (142)) may be located in the third space (S3) inside the indicator (124). Since the needle moving part (142) is fixed to the indicator (124) of the piston (120), the lower end of the needle moving part (142) can maintain a constant position in the third space (S3) even if the piston (120) moves along the inner surface of the container (111).

[0203] In one embodiment, when the body fluid to be separated by the body fluid component separation device (10") is blood (e.g., the blood (BF") of FIG. 17 and FIG. 18), the target substance of the body fluid component separation device (10") may be PRP contained in the blood. When centrifugation is performed with blood contained in the body fluid component separation device (10"), the blood may be separated into three layers according to the specific gravity of each substance. PRP is contained in the middle layer among the three layers, and the thickness of the middle layer may be significantly smaller than the thickness of the remaining layers. The piston (120) can reduce the volume of the second space (S2) containing the centrifuged blood by moving downward after centrifugation of the blood (i.e., moving away from the lead (112)) and move at least some of the materials of the three separated layers (e.g., through the third space (S3) to the first space (S1)). At this time, the piston (120) can be configured to position the intermediate layer (i.e., the layer containing the target material PRP) in the third space (S3) defined by the indicator (124).

[0204] The needle moving part (142) may be configured such that when the target material is located in the third space (S3), the lower end of the needle moving part (142) is located on the same plane as the lower end of the needle fixed part (141) or is located below the lower end of the needle fixed part (141). Even if the piston (120) is moved further down, the lower end of the needle moving part (142) may be located in the third space (S3). When the piston (120) is moved a predetermined distance away from the lead (112), the lower end of the needle moving part (142) may become an open part (i.e., the lower end of the first needle (140A)) through which material flows into the first needle (140A). In this case, since the lower end of the needle moving part (142) forming the lower end of the first needle (140A) can maintain a constant position in the third space (S3), the target material (e.g., PRP) located in the third space (S3) can be efficiently extracted out of the container (111) through the first needle (140A).

[0205] The second needle (140B) may be configured to inject the fluid to be separated by the body fluid component separation device (10) into the container. Additionally, the second needle (140B) may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10) to the outside of the container (111). The second needle (140B) may be at least partially accommodated in the sealed space of the housing (110).

[0206] The second needle (140B) can be inserted into the second opening (O2). Thus, the second needle (140B) can be accommodated at least partially in the sealed space of the housing (110). The second needle (140B) can maintain a fixed position relative to the housing (110), particularly relative to the lead (112), by being coupled to the second needle coupling portion (C2). The second needle (140B) may have a cylindrical shape having an open upper end and a lower end. The lower end of the second needle (140B) may be located in the first space (S1).

[0207] In one embodiment, the second needle (140B) may be inserted into the third opening (O3) instead of the second opening (O2) and may be coupled to the third needle coupling part.

[0208] In one embodiment, the body fluid component separation device (10) may further include a third needle. In this embodiment, the second needle (140B) may be inserted into the second opening (O2), and the third needle may be inserted into the third opening (O3). The third needle may have a cylindrical shape having an open upper end and a lower end, and the lower end of the third needle may be located in the first space (S1). The third needle may be configured to inject the fluid to be separated by the body fluid component separation device (10) into a container, and may be configured to extract some material from the fluid centrifuged by the body fluid component separation device (10) to the outside of the container (111).

[0209] The second needle (140B) and / or the third needle may be positioned at an angle with respect to the central axis (C-C'). In one embodiment, the second needle (140B) and / or the third needle may be configured to extract material contained in the groove (1231) to the outside of the container (111).

[0210] The needle support (150) can connect the first needle (140A) and the indicator (124) of the piston (120) to each other. Specifically, it can connect the needle moving part (142) of the first needle (140A) and the inner body (122) of the piston (120) to each other. Thus, the needle support (150) can allow the needle moving part (142) to be fixed to the indicator (124). The needle support (150) can be located in a third space (S3). The needle support (150) can be positioned immediately adjacent to the second indicator end (1242) in the third space (S3). That is, the upper end of the needle support (150) and the second indicator end (1242) can be located on the same plane.

[0211] Since the needle moving part (142) is fixed to the indicator (124), the open lower end of the needle moving part (142) (i.e., the part where the fluid component flows into the first needle (140A)) can be maintained in a constant position relative to the indicator (124).

[0212] The needle support (150) may include a support body (151) and a plurality of support arms (152). The support body (151) may have a sleeve shape that at least partially encloses the needle moving portion (142) of the first needle (140A). The needle moving portion (142) may be inserted into the needle hole (1511) of the support body (151). The plurality of support arms (152) may be arranged circumferentially along the outer surface of the support body (151). The plurality of support arms (152) may be arranged circumferentially along the inner surface of the indicator (1243B). Each support arm (152) may extend from the support body (151) to the inner surface of the indicator (1243B).

[0213] In one embodiment, the needle support (150) may be formed integrally with the indicator (124). In one embodiment, the needle support (150) may be formed as a separate component from the indicator (124) and may be coupled to the indicator (124) by any suitable means.

[0214] Referring particularly to FIG. 17, with the handle (131) removed, the user can attach an external unit (e.g., a syringe) to the first plug (114A") and inject the body fluid to be separated into the second space (S2") of the container (111") below the piston (120") through the first needle (140A"). FIG. 17 illustrates the case where the body fluid to be separated is blood (BF"), but as previously described, the body fluid to be separated by the body fluid component separation device (10") can be any other body fluid, such as bone marrow. When the body fluid to be separated is blood (BF"), the body fluid component separation device (10") can be used to separate PRP from the blood (BF"), and PRP becomes the target substance of the body fluid component separation device (10).

[0215] Afterward, the user can attach the handle (131) and operate the handle (131) to lower the piston (120) to the volume of blood (BF) so that the piston sealing ring (125) is close to the blood (BF) and the piston (120) is positioned and fixed.

[0216] As the piston (120) descends (i.e., as it moves away from the lead (112)), the needle moving portion (142) of the first needle (140A) can descend together with the piston (120) because the needle moving portion (142) is connected to the piston (120) by the needle support (150). At this time, the lower end of the needle moving portion (142) may be configured to be located substantially in the same plane as the lower end of the needle fixed portion (141). Alternatively, the lower end of the needle moving portion (142) may be configured to be located below the lower end of the needle fixed portion (141) (i.e., further away from the lead (112)).

[0217] Afterward, when centrifugation is performed on the body fluid component separation device (10) with the handle (131) attached, the blood (BF) can be separated into a layer containing the first substance (M1) and a layer containing the second substance (M2) and a layer containing the third substance (M3) according to the specific gravity of each substance. A layer containing a first substance (M1"), a layer containing a second substance (M2"), and a layer containing a third substance (M3") can be formed from the bottom of the container (111") (i.e., the layer containing the first substance (M1") is located at the bottom, the layer containing the third substance (M3") is located at the top, and the layer containing the second substance (M2") is located in the middle). For example, the first substance (M1") may contain red blood cells, the second substance (M2") may contain PRP and concentrated bone marrow cells, and the third substance (M3") may contain platelet-poor plasma, fats, and oils. In particular, the layer containing the second substance (M2") may have a significantly smaller thickness compared to the layer containing the first substance (M1") and the layer containing the third substance (M3").

[0218] Referring particularly to FIG. 18, when a user grasps the handle (131) and rotates the handle (131), the first engaging member (136A) rotates together with the handle (131), and the second engaging member (136B) engaged with the first engaging member (136A) can rotate. Then, the shaft (1371) connected to the second engaging member (136B) rotates and engages with the male engaging element (1372) formed on the shaft (1371), and can move by a predetermined pitch distance of the male engaging element (1372). Accordingly, the piston (120) equipped with the female engaging element (1373) descends by the same predetermined pitch distance as above together with the female engaging element (1373). At this time, the piston (120) can move in a direction closer to the lead (112) so that the target material (i.e., PRP and the second material (M2) containing it) is located in the third space (S3) (i.e., rising).

[0219] When the piston (120) descends, the volume of the second space (S2) decreases and the pressure increases, and the volume of the first space (S1) increases and the pressure decreases by a corresponding amount. At this time, the housing (110) is sealed and the first space (S1) and the second space (S2) are fluidly connected, so that the first space (S1) and the second space (S2) can maintain pressure equilibrium.

[0220] As the volume of the second space (S2) decreases and the pressure increases, and as the volume of the first space (S1) increases and the pressure decreases, the body fluid separated into multiple layers after centrifugation can flow through the third space (S3) inside the indicator (124) while substantially maintaining the separated state. The third substance (M3) can flow along the partition (123) and the indicator (124) to fill the first space (S1). The second substance (M2) can flow along the partition (123) to fill the third space (S3) up to a predetermined height of the indicator (124).

[0221] When the piston (120) descends, the needle moving part (142) of the first needle (140A) fixed to the indicator (124) also descends together, forming the lower end of the first needle (140A), and the lower end of the needle moving part (142) may maintain a constant position in the third space (S3).

[0222] Afterward, the user removes the handle (131) and connects the extraction means to the first plug (114A) to extract the second substance (M2) in the third space (S3) out of the container (111) through the needle moving part (142) of the first needle (140A). After this process, the first substance (M1) is substantially left mainly in the first space (S1), and a small amount of the second substance (M2) remains that is not extracted by the extraction means.

[0223] Although the embodiments described above have been explained with reference to limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, appropriate results can be achieved even if the described techniques are performed in a different order than described, and / or the components of the described system, structure, device, circuit, etc. are combined or assembled in a form different from described, or replaced or substituted by other components or equivalents.

[0224] Therefore, other implementations, other embodiments, and equivalents to the claims also fall within the scope of the claims set forth below.

Claims

Housing having a sealed space, A piston configured to be received in the housing so as to be sealed with the housing and to be movable along the longitudinal direction of the housing, wherein the piston, A first partition for defining a first space in the above-mentioned sealed space, A second partition for defining a second space located below the first space in the above-mentioned sealed space, and A fluid passage defining a third space connected to the first partition and the second partition, fluidly communicating the first space and the second space. The piston including A needle that is at least partially accommodated in the above-mentioned sealed space, wherein the needle The upper part of the needle fixed to the above housing, and A lower needle configured to be movable relative to the upper needle by the movement of the piston. The needle, including, and A needle support connecting the lower part of the needle and the piston so that the lower part of the needle maintains a fixed position relative to the piston. A body fluid component separation device including In Article 1, The lower end of the needle above is a body fluid component separation device located in the third space above. In Article 1, The above needle support is, Support body, and A body fluid component separation device comprising a plurality of support arms extending from the support body to the piston. In Paragraph 3, The above plurality of support arms are a fluid component separation device having preload. In Paragraph 3, The above plurality of support arms are a fluid component separation device inclined with respect to the support body. In Article 1, The above needle support is a body fluid component separation device comprising an elastic material. In Article 1, A body fluid component separation device in which the upper part of the needle and the lower part of the needle overlap at least partially. In Article 1, A body fluid component separation device in which the diameter of the upper part of the needle is larger than the diameter of the lower part of the needle. In Article 1, The first partition and the second partition are a body fluid component separation device inclined in opposite directions. In Article 1, A body fluid component separation device further comprising a manipulator operably coupled to the piston, said manipulator configured to control the movement of the piston between a first position and a second position located below the first position. In Article 10, The above manipulator is, handle, A first engaging member formed on the handle, A second interlocking member configured to interlock with the first interlocking member, A shaft coupled with the second interlocking member, A first engaging element formed on the shaft, and A second engagement element configured to engage with the first engagement element and installed on the piston A body fluid component separation device including In Article 11, A body fluid component separation device in which the first interlocking element is a male interlocking element and the second interlocking element is a female interlocking element. In Article 1, The above housing is, A container maintaining the above piston and seal, and A lid that seals the container to define the above-mentioned sealed space and is coupled to the container, wherein the lid An opening fluidly communicating with the above-mentioned sealed space and into which the upper portion of the needle is at least partially inserted, and A deformable plug that opens and closes the above opening The lead including A body fluid component separation device including In Article 11, The above piston is, An outer body moving along the longitudinal direction of the above housing, and An inner body located inside the above outer body Includes, The inner body is configured so that the rotational force of the shaft is not transmitted to the materials located in the first space, the second space, and the third space when the shaft rotates, and The above inner body is a body fluid component separation device that prevents a material located in the first space, the second space, and the third space from contacting the shaft, the first engaging element, and the second engaging element. In Article 11, The above piston is configured to receive a target material comprising a first material, a second material, and a third material, and A body fluid component separation device configured such that the handle and the second interlocking member operate to position the first substance in the first space, position the second substance in the second space, and position the third substance in the third space. In Article 1, A body fluid component separation device further comprising a piston guide configured to prevent rotation of the above-mentioned piston and guide its movement. Housing including a container and a lid that define a space sealed from the outside; A piston configured to separate the sealed space of the housing into a first space and a second space, fluidly connect the first space and the second space, and be movable along the inner surface of the container in the longitudinal direction of the container; A first needle at least partially accommodated in a sealed space of the above housing, wherein the first needle is, The upper part of the needle fixed to the above lead; and A lower needle configured to be movable relative to the upper needle by the movement of the piston. The first needle comprising; and A needle support connecting the lower part of the needle and the piston so that the lower part of the needle maintains a fixed position relative to the piston, wherein the needle support is A support body that at least partially surrounds the lower part of the needle; and A support arm connecting the support body and the piston The needle support including A body fluid component separation device including In Article 17, The above piston is, An outer body moving along the longitudinal direction of the above container; and An inner body located inside the above outer body Includes, The above needle support is a fluid component separation device connected to the above internal body. In Article 17, The above support body is a body fluid component separation device comprising a needle hole into which the lower part of the needle is inserted. In Article 17, A body fluid component separation device in which the diameter of the lower part of the needle is larger than the diameter of the upper part of the needle. In Article 17, A body fluid component separation device in which the diameter of the lower part of the needle is smaller than the diameter of the upper part of the needle. In Article 17, The above piston is, A first partition defining the above-mentioned first space; A second partition located below the first space and for defining the second space; and It includes a fluid passage defining a third space that is connected to the first partition and the second partition and fluidly communicates with the first space and the second space, and The lower end of the needle above is a body fluid component separation device located in the third space. In Article 17, The above lead includes a first opening, a second opening, and a third opening capable of fluid communication with the above-mentioned sealed space, and The first opening is located at the center of the lead, and The above second opening and the above third opening are a body fluid component separation device located at the periphery of the lead surrounding the above center. In Article 23, The above lead is, A first plug for opening and closing the first opening; A second plug for opening and closing the second opening; and A third plug that opens and closes the third opening. Includes, The first plug, the second plug, and the third plug are configured to be deformable, forming a body fluid component separation device. In Article 23, The first needle is inserted at least partially into the first opening, and A body fluid component separation device further comprising a second needle inserted at least partially into the second opening or the third opening. In Article 17, It further includes a manipulator configured to move the piston relative to the housing, and The above manipulator is, A shaft having a rotation axis and configured to be rotatable about the rotation axis; A male engagement element formed along the axial direction of the rotation axis of the shaft; and A body fluid component separation device comprising a female interlocking element configured to interlock with the male interlocking element. In Article 26, The above piston is, An outer body moving along the longitudinal direction of the above container; and An inner body located inside the above outer body Includes, The shaft, the male engagement element, and the female engagement element are located at least partially inside the inner body, and The above-described inner body is a fluid component separation device configured to prevent materials located in the sealed space of the housing from coming into contact with the shaft, the male interlocking element, and the female interlocking element. In Article 27, The above internal body is, A first longitudinal portion having a first inner diameter; and It includes a second longitudinal portion connected to the first longitudinal portion and having a second inner diameter smaller than the first inner diameter, A step is formed between the first longitudinal portion and the second longitudinal portion, and The above-mentioned arm interlocking element is a body fluid component separation device limited by the above-mentioned step. In Article 27, It further includes a piston guide configured to guide the movement of the above piston and connected to the above lead, and The inner body is located inside the piston guide, and at least a portion of the outer surface of the inner body is in contact with at least a portion of the inner surface of the piston guide, and The inner body and the piston guide are positioned at an angle with respect to the central axis of the container, and The inner body and the piston guide are configured to prevent rotation of the piston, and The above-described internal body is a body fluid component separation device configured so that the rotational force of the shaft is not transmitted to materials located in the sealed space of the housing when the shaft rotates. Housing including a container and a lid that define a space sealed from the outside; A piston configured to be movable along the inner surface of the container in the longitudinal direction of the container, wherein the piston, A partition separating the sealed space of the above housing into a first space and a second space; and An indicator configured to indicate a layer comprising a third space connected to the partition and fluidly communicating with the first space and the second space, and a target substance flowing from the first space to the second space. The piston including; and A needle that is at least partially accommodated in the sealed space of the above housing and at least partially located in the third space, wherein the needle is, A needle fixing part fixed to the above lead; and A needle moving part that is fixed to the indicator, overlaps at least partially with the needle fixing part, and is configured to move along the outer surface of the needle fixing part when the piston moves. The needle including Includes, The piston is configured to move away from the lead to position the target material in the third space, and A body fluid component separation device configured such that, when the target substance is located in the third space, the lower end of the needle fixing part and the lower end of the needle moving part are located on the same plane or the lower end of the needle moving part is located below the lower end of the needle fixing part, and the lower end of the needle moving part is located at a certain position in the third space. In Article 30, A body fluid component separation device in which the length of the above-mentioned needle moving part is less than or equal to the length of the above-mentioned needle fixing part. In Article 30, A body fluid component separation device in which the inner diameter of the needle moving part is the same as the outer diameter of the needle fixing part. In Article 30, The indicator further includes a needle support located in the third space that connects the needle moving part and the indicator so that the needle moving part is fixed to the indicator, and The above indicator includes an inner surface of the indicator defining the third space, and an outer surface of the indicator opposite to the inner surface of the indicator, The above needle support is, A support body that at least partially encloses the above-mentioned needle moving portion; and A body fluid component separation device comprising a plurality of support arms, wherein each support arm extends from the support body to the inner surface of the indicator, and the plurality of support arms are arranged circumferentially along the inner surface of the indicator. In Article 33, The above indicator is, A first indicator end connected to the above partition; and It includes a second indicator end opposite to the first indicator end, and The above needle support is a body fluid component separation device positioned immediately adjacent to the end of the second indicator.